Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class with analgesic and antipyretic properties. Meloxicam inhibits prostaglandin synthetase (cylooxygenase (COX) 1 and 2) and leads to a decrease of the synthesis of prostaglandins, which contribute to inflammation of joints. Many commercially available NSAID drugs are COX inhibitors, which inhibit both COX1 and COX2. A general inhibition of COX may provide the benefits of anti-inflammatory, analgesic and antipyretic effects. However, it also causes serious side effects such as digestive disorders and renal disorders. It is believed that COX1 is constitutively expressed in most organs (e.g., stomach or kidney). See Vane et al., Proc. Natl. Acad. Sci. USA, 91:2046-2050 (1994); Oulette et al., Proc. Natl. Acad. Sci., 98:14583-14588 (2001); and Seibert et al., Proc. Natl. Acad. Sci., 91:12013-12017 (1994). In contrast, COX-2 is induced by various inflammatory mediators or endotoxin in local inflammatory areas. See Smith et al., Proc. Natl. Acad. Sci., 95:13313-13318 (1998). Meloxicam is a selective COX2 inhibitor, which may avoid the side effects of COX1 inhibitors.
Currently, meloxicam is available in both injectable and oral dosage forms (tablet and suspension) for humans. In addition, it has also been approved for veterinary uses for dogs in the U.S. and for cats in Europe, Australia and New Zealand. Some of the trade names under which meloxicam has been or is marketed include MOBIC®, MOBEC®, MOBICOX®, MOVALIS®, and MOVATEC®. The form of meloxicam currently marketed in the United States is MOBIC®, provided in 7.5 and 15 mg tablets.
Meloxicam has been shown to be useful in the symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease), symptomatic treatment of rheumatoid arthritis, and symptomatic treatment of the signs and symptoms of osteoarthritis, including pain, stiffness, and inflammation. Because of meloxicam's broad uses, there is an industrial need to provide an oral dosage form with an improved ease of administration and patient compliance.